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Rooming-In could keep NAS babies out of the NICU

NCT ID NCT05226624

Disease control Sponsor: University of Alberta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a 'rooming-in' approach where mothers and babies stay together in a quiet hospital room instead of separating the baby to the NICU. About 240 full-term infants exposed to opioids during pregnancy will take part across Alberta hospitals. The goal is to reduce NICU stays, increase breastfeeding, and help more babies go home with their mothers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rooming-in care (keeping mothers and babies together in a quiet hospital room)
What this could lead to
If successful, this program could reduce the need for NICU stays, increase breastfeeding, and help more babies go home with their mothers, lowering healthcare and social costs.
What could go wrong
This is a hospital-level program, not a drug or cure. Results depend on how well hospitals adopt the change, and benefits may vary across sites. The study is still recruiting, so outcomes are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infants born at \>36 weeks gestation to mothers who report opiate use during pregnancy (or who are in an ODP/VODP program) and who are admitted to a participating implementation project hospital. Exclusion Criteria: * Infants born at less than 36 weeks and/or birth weight less than 2000 grams and infants with congenital anomalies will be excluded as these infants would be expected to be admitted to NICU.

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neonatal abstinence syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2C8, Canada

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